Chapter 2: Ethics and Research

Total Page:16

File Type:pdf, Size:1020Kb

Chapter 2: Ethics and Research Ethics and Research 2 hapter 2 is a discussion and review of ethical issues in conducting and using research. CAn important question is this: Why study ethics and research? First, it is import- ant that the researcher is aware of how ethical his or her procedures are in conducting research. There are federal laws that protect human subjects against potentially harmful research practices (Office for Human Research Protections [OHRP] of the U.S. Depart- ment of Health and Human Services). The specific regulations may be founddistribute in the U.S. federal code of regulation, 45 CFR 46 and the Common Rule: 45 CFR 46 subpart A. There is a relatively short history of human research protection starting in 1974, the National Research Act (Pub L. 93-348). The Belmont Report was published to clarify and summarize the act. Due to several high-profile research studiesor that resulted in harm to participants, Congress passed the act. Several of these research studies are discussed later in this chapter. While protecting subjects and adhering to federal laws are most relevant for researchers conducting research, I will not go into great detail here because the focus of this book is designed to prepare you to be a thoughtful consumer of research. What dif- ference does it make to consider ethical issues in the articles you read in the professional literature? The answers to these questions post,are the foci of this chapter. The purpose of this chapter is threefold: first, to introduce you to ethical guidelines helpful in understanding ethics and research; second, to discuss examples of ethical research violations; and third, more important for you as a practitioner, to provide a method of evaluating the ethics of a research design as ethics apply to your use in actual practice of the information from the research. Therefore, this chapter includes (a) discus- sion of basic principles that may be used to consider and understand ethics and research, (b) a foundation andcopy, set of criteria for evaluating research reported in the literature, with a particular focus on the ethics of the research design as the results apply to using the information in actual practice, and (c) a discussion of examples from the current literature, which will illustrate how to use the criteria presented earlier in evaluating research for violations and problems from an ethical perspective for the practitioner in counselingnot and education. ETHICAL PRINCIPLES AND GUIDELINES DoWhen one considers ethical issues in research, it is helpful to conceptualize the guidelines available in the form of an inverted triangle (see Figure 2.1). At the top of the inverted triangle are general theories of ethics, and you may think of the space in this segment 23 Copyright ©2020 by SAGE Publications, Inc. This work may not be reproduced or distributed in any form or by any means without express written permission of the publisher. FIGURE 2.1 Ethical Guidelines for Research Utilitarianism Ethical Theories Deontological Autonomy, Beneficence, Justice, Ethical Principles Nonmaleficence, and Fidelity Professional Codes of Ethics ACA Code APA Code Human distribute Laws: State and Federal Subjects Guidelines or of the triangle as representing the number of situations that can be addressed with the theories. Also, the space may represent the amount of ambiguity in decision-making because there is not the specific claritypost, that some of the other guides listed in the triangle provide. Next are general principles such as autonomy, nonmaleficence, and so on. These general principles allow for a somewhat clearer interpretation than the general theories but do not allow the same number of situations to be addressed. The third type of guide is the professional ethical code, such as that of the American Psychological Association (APA) or the American Counseling Association (ACA). (I did not include the National Education Association [NEA] codes because they do not address research.) As we move down the trianglecopy, with the codes of ethics, there is an increased clarity in how and when to use the guidelines and a decrease in the number of situations to which they can be applied. Finally, at the bottom of the triangle, are laws and federal or state statutes and regulations. These are the most specific and clear-cut guides for ethical decision-making, but they apply to (generally) the fewest situations and circumstances. notStarting at the top of the triangle, you can see that two major types of theories have been proposed in ethical decision-making: utilitarian ethics and a deontological view (Beauchamp & Childress, 2012). There are several other ethical theories that could be included in ethical decision-making (Houser & Thoma, 2012; Houser, Wilczenski, & Do Ham, 2006). However, this book is not solely focused on ethics, so I will cover these two broad theories (utilitarian and deontological). Federal regulations (OHRP) as well as 24 SECTION I INTRODUCTION TO THE RESEARCH PROCESS Copyright ©2020 by SAGE Publications, Inc. This work may not be reproduced or distributed in any form or by any means without express written permission of the publisher. state and federal laws generally use these two ethical theories in developing their guide- lines or laws. Beauchamp and Childress (2012) defined utilitarian theory in terms of the end justifying or legitimizing the means and the promotion of the greatest good for the greatest number of people. Ethical decision-making can be applied to a great number of situations, but how to proceed is not that clear. Beauchamp and Childress defined the deontological approach in terms of decisions about right and wrong. There are rules or principles of right and wrong. For example, one rule within this theory is the Golden Rule (treat others as you would like to be treated) that guides actions (Beauchamp & Childress, 2012). In this theory, the outcome is less important than following the rule or principle. The next level of ethical guidelines is that of general principles, which are founded on virtue ethics (found within the deontological perspective). The general principles include autonomy, beneficence, nonmaleficence, justice, and fidelity (Beauchamp & Childress, 2012). According to Beauchamp and Childress, autonomy involves the concept of self- rule and self-choice. Self-choice includes full disclosure of information, which makes it possible to make an informed choice. Beneficence refers to doing what is best for another or looking out for another, whereas nonmaleficence is complementarydistribute to benef- icence and concerns doing no intentional harm. Justice involves the fair distribution of resources. Finally, fidelity refers to keeping one’s promise or commitment (Beauchamp & Childress, 2012). The next level of ethical guidelines is that ofor professional codes of ethics (ACA, 2014; APA, 2010). The ethical codes for the ACA address the follow- ing areas, under research: (a) research responsibilities of the counselor (Standard G.1), (b) rights of research participants (Standard G.2), (c) managing and maintaining bound- aries (Standard G.3), (d) reporting results (Standard G.4), and (e) publications and presentations (Standard G. 5). An example of rights of participants (Standard G.2) is as follows: The researcher needs to obtain informed consent for research pur- poses, and counselors must use language post,that is clear and understandable to partic- ipants. There are exceptions, when deception is required in a study, but deception is used only when no other methods are available. The APA (2003) Ethics Code Sec- tion 8 addresses (a) institutional approval (Standard 8.01), (b) informed consent for research (Standard 8.02), (c) Informed consent for recording voices and images in research (Standard 8.03), (d) client/patient, student, and subordinate research partic- ipants (Standard 8.04), (e) dispensing with informed consent for research (Standard 8.05), (f) offering inducementscopy, for research participation (Standard 8.06), (g) deception in research (Standard 8.07), (h) debriefing (Standard 8.08), (i) humane care and use of animals in research (Standard 8.09), (j) reporting research results (Standard 8.10), and (k) plagiarism (Standard 8.11). These topics in both the ACA and APA codes of ethics provide resources for practitioners who conduct or use research studies. You can review the relevantnot codes as necessary. Finally, there are ethical guides that address specific procedures for the protection of human subjects (OHRP). Federal legislation (OHRP) requires that investigators who are associated with institutions that receive federal funds must submit their studies to an Doextensive review by peers before the studies can be conducted. The primary focus is on ensuring that adequate protections for research subjects are in place. The peer review is CHAPTER 2 ETHICS AND RESEARCH 25 Copyright ©2020 by SAGE Publications, Inc. This work may not be reproduced or distributed in any form or by any means without express written permission of the publisher. done through a formally established institutional body, the Human Subjects Institutional Review Board (IRB). Guidelines for reviewing research proposals include requirements for informed consent, an evaluation of risks and benefits, and confidentiality. The IRB must evaluate the risks as being reasonable in relation to anticipated benefits. Professional Association Standards for Research (American Counseling Association and National Education Association) The 2014 ACA Code of Ethics includes a specific
Recommended publications
  • International Regulation of Human Subject Experimentation
    04__LAUGHTON.DOC 5/27/2008 1:29:05 PM SOMEWHERE TO RUN, SOMEWHERE TO HIDE?: INTERNATIONAL REGULATION OF HUMAN SUBJECT EXPERIMENTATION ADAM H. LAUGHTON* INTRODUCTION The pharmaceutical industry is one of the most important players in the field of clinical research on human beings. Increasingly in recent years, “Big Pharma” in the United States and elsewhere has turned to foreign populations to test its new products. The purpose of this note is to examine how existing sources of quasi-legal and ethical regulation address the troublesome issues raised by this increase in international human experimentation. First, the note gives a brief history of human experimentation and its regulation, giving special focus to the events of the twentieth century that have most affected the development of the bioethics movement. Next, it describes and compares several instruments of international regulation of human subject experimentation. Finally, it examines some of the difficult ethical issues associated with international research on human subjects. In this discussion, the greatest amount of attention will be given to clinical trials performed by the pharmaceutical industry. Other types of international research on human subjects exist, but research by the pharmaceutical companies poses its own special regulatory and ethical problems. I. HISTORY AND BACKGROUND A. Pre-Nuremberg Though the Holocaust and the concurrent Nazi experimentation on prisoners and Jews1 brought unprecedented attention to Copyright © 2007 by Adam H. Laughton. * Adam H. Laughton is a J.D. candidate at Duke University School of Law and an Executive Editor of the Duke Journal of Comparative and International Law. He would like to thank his wife Ariel Bybee Laughton for her constant support in all of his academic endeavors.
    [Show full text]
  • IRB Presentation
    Institutional Review of Research Involving Human Participants IRB Presentation University of Central Florida Office of Research & Commercialization 407-823-2901 or fax 407-823-3299 www.research.ucf.edu/Compliance/irb.html 1 University of Central Florida Institutional Review Board Overview Sophia F. Dziegielewski, Ph.D., LCSW IRB Chair Michael G. Deichen, MD, MPH IRB Vice Chair IRB Office Staff: Joanne Muratori, MA, CIP, CIM Patria Davis, MSP, CIP Kamille Chaparro, BS Gillian Morien, BS 2 IRB Function The purpose of an IRB is to review research involving human subjects to ensure their rights and welfare are adequately protected. 3 The Role of the IRB Members Charged with safeguarding the rights and welfare of human subjects. Duties include reviewing protocols that involve the use of human subjects. Assist and guide researchers to help protect the rights of human subjects 4 Research Ethics Why Do Human Research Subjects Need Protection? Trigger Events • The Nazi Experiments • Tuskegee Syphilis Study • Milgram’s Studies • Rosenhan Studies • Laud Humprey’s 6 Trigger Events: “What we have learned from history…” Nazi experimentation on concentration camp prisoners Tuskeegee Syphilis Study Milgram Study 7 Do we have a right to use information gathered unethically? Prisoner of War camps in Asia and Europe: practiced mutilation surgery, tested antibiotics, affects of cold, injured people to study the healing process. Tuskegee Experiments: Physical Harm 1932 took 625 black males and studied the course of syphilis. 425 were diagnosed as having syphilis and the remainder were used as a control. In 1937 we discovered Penicillin but still did not give it to the men.
    [Show full text]
  • THE ROLE of INSTITUTIONAL REVIEW BOARDS in AVIATION RESEARCH: IT's the LAW and IT MAKES SENSE Dr
    THE ROLE OF INSTITUTIONAL REVIEW BOARDS IN AVIATION RESEARCH: IT'S THE LAW AND IT MAKES SENSE Dr. Earl S. Stein FAA, William J. Hughes Technical Center Atlantic City International Airport, New Jersey Research in medicine and social sciences often involves the participation of human participants, who under the rules in place today volunteer their time and understand both the benefits and risks associated with the research. This was not always the case. Rules, regulations, and laws currently require oversight by organizations referred to as Institutional Review Boards (IRBs). These boards exist to protect the participants, ensure their ethical treatment, and encourage good research. IRBs enhance the quality of research planning, and the IRB process should be part of every researcher's timeline for completion of his/her projects. example of the CIA's LSD research program. He was Research involves a systematic search for a reality given LSD without informed or any other consent; it that transcends our concepts as individuals. While led to depression and his suicide (Elliston, 2004). The philosophers will debate that there are many realities, US Army also experimented with LSD and a in science we attempt to narrow the options. In social psychoactive gas, quinuclindnyl benzilate (BZ), from science we usually state our conclusions in 1955 to 1975 at Edgewood Arsenal Maryland, on probabilistic terms, admitting that there is some soldier "volunteers", who were told they would chance we could be wrong. experience transitory discomfort and could terminate We base our conclusions on data gathered from the the experiment any time they wished but only with systematic study of some phenomenon such as the consent of the physician in charge (Edgewood behavior.
    [Show full text]
  • Protecting Human Research Participants NIH Office of Extramural Research Introduction
    Protecting Human Research Participants NIH Office of Extramural Research Introduction Research with human subjects can occasionally result in a dilemma for investigators. When the goals of the research are designed to make major contributions to a field, such as improving the understanding of a disease process or determining the efficacy of an intervention, investigators may perceive the outcomes of their studies to be more important than providing protections for individual participants in the research. Although it is understandable to focus on goals, our society values the rights and welfare of individuals. It is not considered ethical behavior to use individuals solely as means to an end. The importance of demonstrating respect for research participants is reflected in the principles used to define ethical research and the regulations, policies, and guidance that describe the implementation of those principles. Who? This course is intended for use by individuals involved in the design and/or conduct of National Institutes of Health (NIH) funded human subjects research. What? This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants. Why? As a part of NIH's commitment to the protection of human subjects and its response to Federal mandates for increased emphasis on protection for human subjects in research, the NIH Office of Extramural Research released a policy on Required Education in the Protection of Human Research Participants in June 2000.
    [Show full text]
  • Minimal Risk: 45 CFR 46.102(I)
    Protecting Human Subjects -- b Carleton College October 10, 2002 Tom Puglisi,What PhD Everyone 3&Needs to Know The Protection of Human Subjects in Research Medical Research Summit Michele Russell-Einhorn, JD Tom Puglisi, PhD May 5, 2003 3& ©2002 PricewaterhouseCoopers. PricewaterhouseCoopers refers to the individual member firms of the world-wide PricewaterhouseCoopers organisation. All rights reserved. PricewaterhouseCoopers PricewaterhouseCoopers PricewaterhouseCoopers Government Shutdowns Massachusetts Eye and Ear Infirmary UCLA VA Health Sys. Greater Los Angeles Rush Presbyterian St Luke’s Med Ctr. University of Illinois Chicago Duke University Med Ctr. Univ. Texas Medical Branch Galveston University of Oklahoma Tulsa Johns Hopkins University PricewaterhouseCoopers Research Involving Human Subjects Human Research Halted at Major Institutions – Deficient Informed Consent – Inadequate Initial and Continuing IRB Review – Multiple Areas of Concern Death in Gene Transfer Research – Conflicts of Interest – Unreported Deaths and Injuries Media Attention – Congressional Hearings – Distrust PricewaterhouseCoopers Research Involving Human Subjects “What’s at Stake is the Integrity of Research and Public Confidence in Research” -- HHS Secretary, Donna Shalala, May 2000 PricewaterhouseCoopers Historical Overview 3& Historical Overview Nazi Doctor Trials – Nuremberg Code – 1947 – Informed Consent Declaration of Helsinki – World Medical Association – Ethical Principles for Medical Research Involving Human Subjects 1964 (revised 2000)
    [Show full text]
  • Exploitation in Medical Research: the Enduring Legacy of the Tuskegee Syphilis Study
    Case Western Reserve University School of Law Scholarly Commons Faculty Publications 2017 Exploitation in Medical Research: The Enduring Legacy of the Tuskegee Syphilis Study Ruqaiijah Yearby Case Western Reserve University - School of Law, [email protected] Follow this and additional works at: https://scholarlycommons.law.case.edu/faculty_publications Part of the Health Law and Policy Commons Repository Citation Yearby, Ruqaiijah, "Exploitation in Medical Research: The Enduring Legacy of the Tuskegee Syphilis Study" (2017). Faculty Publications. 2002. https://scholarlycommons.law.case.edu/faculty_publications/2002 This Article is brought to you for free and open access by Case Western Reserve University School of Law Scholarly Commons. It has been accepted for inclusion in Faculty Publications by an authorized administrator of Case Western Reserve University School of Law Scholarly Commons. Case Western Reserve Law Review·Volume 67·Issue 4·2017 Exploitation in Medical Research: The Enduring Legacy of the Tuskegee Syphilis Study Ruqaiijah Yearby† Contents Introduction ................................................................................. 1172 I. Medical Research Studies Involving Children: The Structure and History......................................................... 1177 A. Structure of Medical Research Studies Involving Human Subjects .... 1178 B. The Belmont Report ................................................................... 1181 C. The Common Rule ....................................................................
    [Show full text]
  • Regulating Research with Decisionally Impaired Individuals: Are We Making Progress?
    DePaul Journal of Health Care Law Volume 3 Issue 3 Issue 3 & 4 Spring/Summer 2000: Symposium - Medical Research: Legal and Article 7 Ethical Implications November 2015 Regulating Research with Decisionally Impaired Individuals: Are We Making Progress? Diane E. Hoffmann Jack Schwartz Evan G. DeRenzo Follow this and additional works at: https://via.library.depaul.edu/jhcl Recommended Citation Diane E. Hoffmann, Jack Schwartz & Evan G. DeRenzo, Regulating Research with Decisionally Impaired Individuals: Are We Making Progress?, 3 DePaul J. Health Care L. 547 (2000) Available at: https://via.library.depaul.edu/jhcl/vol3/iss3/7 This Article is brought to you for free and open access by the College of Law at Via Sapientiae. It has been accepted for inclusion in DePaul Journal of Health Care Law by an authorized editor of Via Sapientiae. For more information, please contact [email protected]. REGULATING RESEARCH WITH DECISIONALLY IMPAIRED INDIVIDUALS: ARE WE MAKING PROGRESS? Diane E. Hoffinann* Jack Schwartz** Evan G. DeRenzo*** INTRODUCTION'" The National Bioethics Advisory Commission (NBAC or Commission), as well as advisory panels in two states (New York and Maryland) have recently issued recommendations urging new regulation of research with decisionally impaired individuals.! These 'Professor of Law, University of Maryland School of Law. A.B., Duke University, 1976; M.S., Harvard School of Public Health, 1980; LD.Harvard Law School, 19S6. * Assistant Attorney General and Director, Health Policy Development, Maryland Oftce of the Attorney General. B.S., University of Maryland Baltimore County, 1972; J.D., Yale Law School, 1975. **Bioethicist, Washington Hospital Center. B.A., Wheaton College, 1973; M.A., George Washington University, 1976; PhD., Univ.
    [Show full text]
  • Cold War Nonconsensual Experiments: the Threat of Neuroweapons and the Danger It Will Happen Again
    1 Cold War Nonconsensual Experiments: The Threat of Neuroweapons and the Danger it will happen again CHERYL WELSH , J.D .* Abstract During the Cold War, the U.S. government experimented on American citizens without their permission. Although nonconsensual experiments are prohibited under the U. S. Constitution, U.S. law allows for waivers and exemptions of informed consent in U.S. government research. This paper examines how and why all major reforms efforts to ban nonconsensual experiments have failed. It examines emerging evidence of secret neuroweapons; neuroscience-based weapons that may be comparable to the atomic bomb and the significant danger of further nonconsensual experiments being carried out today. The paper also reviews the current debate on the persistent allegations that on-going nonconsensual government experiments are happening again and gives recommendations for future reform efforts. Keywords : nonconsensual experiments, U.S. experimentation law, ethics, secrecy, neuroweapons 1. Introduction During the Cold War, the U.S. government experimented on American citizens without their permission. 'The vastness of the human experimentation became clear only in 1994, when the U.S. General Accounting Office reported that hundreds of thousands of Americans were used in military-related experiments involving radiation, blister and nerve agents, biological agents, and LSD between 1940 and 1974.' 1 The 1995 Advisory Committee for Human Radiation Experiments (ACHRE) Final Report called for regulations to halt such human subject experimentation without informed consent. 2 Top U.S. government officials - including Hazel O'Leary, Secretary of the U.S. Department of Energy - stated that such experiments should never happen again. 3 Yet today, some officials still have the power to waive regulations requiring informed consent in classified government experiments.
    [Show full text]
  • JERRY MENIKOFF* the Federally Financed Tuskegee Study of African
    SAINT LOUIS UNIVERSITY SCHOOL OF LAW COULD TUSKEGEE HAPPEN TODAY? JERRY MENIKOFF* The federally financed Tuskegee Study of African American men with syphilis casts a long shadow on the conduct of research involving human subjects in the United States. Even seventy-five years after the study began and thirty-five years after it was publicly exposed by an enterprising reporter,1 overstating its impact remains difficult. In 1997, while issuing a formal apology to the eight remaining survivors of the study, President Clinton characterized the study with these words: [These survivors] are a living link to a time not so very long ago that many Americans would prefer not to remember, but we dare not forget. It was a time when our nation failed to live up to its ideals, when our nation broke the trust with our people that is the very foundation of our democracy. It is not only in remembering that shameful past that we can make amends and repair our nation, but it is in remembering that past that we can build a better present and a better future.2 The spectacle of federal researchers standing by and watching hundreds of poor black men suffer the ravages of syphilis while denying them information about a newly discovered treatment had a profound effect on * Director, Office of Human Subjects Research, and Bioethicist, Department of Bioethics, National Institutes of Health; Associate Professor of Law, Ethics & Medicine, University of Kansas (on leave). The opinions expressed are those of the author and do not necessarily reflect the policy of the National Institutes of Health or the U.S.
    [Show full text]
  • Aidenbaum Course Paper
    Herein of Scandal and Advancement: A Chronicle of Human Experimentation in the United States The Harvard community has made this article openly available. Please share how this access benefits you. Your story matters Citation Whitney Lee Aidenbaum, Herein of Scandal and Advancement: A Chronicle of Human Experimentation in the United States (April 2011). Citable link http://nrs.harvard.edu/urn-3:HUL.InstRepos:8589349 Terms of Use This article was downloaded from Harvard University’s DASH repository, and is made available under the terms and conditions applicable to Other Posted Material, as set forth at http:// nrs.harvard.edu/urn-3:HUL.InstRepos:dash.current.terms-of- use#LAA Herein of Scandal and Advancement: A Chronicle of Human Experimentation in the United States Whitney Lee Aidenbaum Class of 2012 April 2011 This paper is submitted in satisfaction of the course requirement. Abstract An account of the history of human experimentation in the United States necessarily involves a recounting of scandals and the research policies that developed in response. This paper aims to provide a review of this history, along with observations about recurring themes that pervade the narrative. In so doing, this author hopes to provide a useful reference, and also to reveal the inherent tensions and difficult problems posed by the conduct of research using human subjects. In June 1769, 29-year-old physician William Stark began a new diet. For 12 weeks he lived on bread and water with little sugar. William became “dull and listless,” and his gums were swollen and bled easily. In the following three weeks he “quite recovered” by varying his diet.
    [Show full text]
  • Dark Medicine: How the National Research Act Has Failed To
    Seattle Journal for Social Justice Volume 11 Issue 3 Article 11 11-2013 Dark Medicine: How the National Research Act Has Failed to AddrFollow thisess and Racist additional Pr worksactices at: https:/ in/digitalcommons.law Biomedical .seattleu.edu/sjsjExperiments Targeting the African-American Part of the Administrativ eCommunity Law Commons, Agricultur e Law Commons, Arts and Humanities Commons, Banking and Finance Law Commons, Civil Rights and Discrimination Commons, Commercial Law AnietieCommons Maur, Compareen-Annative Akpan and For eign Law Commons, Constitutional Law Commons, Consumer Protection Law Commons, Criminal Law Commons, Criminal Procedure Commons, Disability and Equity in Education Commons, Disability Law Commons, Educational Leadership Commons, Educational Methods Commons, Energy and Utilities Law Commons, Family Law Commons, Fourteenth Amendment Commons, Health Law and Policy Commons, Housing Law Commons, Human Rights Law Commons, Immigration Law Commons, Indian and Aboriginal Law Commons, Insurance Law Commons, Intellectual Property Law Commons, International Trade Law Commons, Juvenile Law Commons, Labor and Employment Law Commons, Land Use Law Commons, Law and Gender Commons, Law and Psychology Commons, Legal Ethics and Professional Responsibility Commons, Legal History Commons, Legal Remedies Commons, Legislation Commons, Marketing Law Commons, National Security Law Commons, Natural Resources Law Commons, Other Education Commons, Other Law Commons, Privacy Law Commons, Property Law and Real Estate Commons, Secured Transactions Commons, Securities Law Commons, Sexuality and the Law Commons, Social and Behavioral Sciences Commons, Social and Philosophical Foundations of Education Commons, Social Welfare Law Commons, Transnational Law Commons, and the Water Law Commons Recommended Citation Akpan, Anietie Maureen-Ann (2013) "Dark Medicine: How the National Research Act Has Failed to Address Racist Practices in Biomedical Experiments Targeting the African-American Community," Seattle Journal for Social Justice: Vol.
    [Show full text]
  • An Analysis of the Common Rule and Its Interactions with FDA Regulations and the HIPAA Privacy Rule
    Order Code RL32909 CRS Report for Congress Received through the CRS Web Federal Protection for Human Research Subjects: An Analysis of the Common Rule and Its Interactions with FDA Regulations and the HIPAA Privacy Rule Updated June 2, 2005 Erin D. Williams Specialist in Bioethical Policy Domestic Social Policy Division Congressional Research Service ˜ The Library of Congress Federal Protection for Human Research Subjects: An Analysis of the Common Rule and Its Interactions with FDA Regulations and the HIPAA Privacy Rule Summary The Common Rule (45 CFR 46, Subpart A) governs research that is conducted on human beings if it is funded by one of 18 federal agencies. It requires a review of proposed research by an Institutional Review Board (IRB), the informed consent of research subjects, and institutional assurances of compliance with the regulations. In 1974, 45 CFR 46 was published following some cases of harm to human subjects, such as those caused by thalidomide drug trials and the United States Public Health Service syphilis study in Tuskeegee, Alabama. The regulations had their roots in numerous international agreements, such as the Nuremberg Code and the Declaration of Helsinki, and domestic policies, such as those put forth by the Department of Health, Education and Welfare (DHEW; now the Department of Health and Human Services, HHS). In 1991, 16 federal agencies adopted 45 CFR 46, Subpart A, which then became known as the Common Rule. Since the Common Rule took effect, events like the death of Jesse Gelsinger in 1999 due to his participation a clinical trial have prompted scrutiny of the Rule and its ability to protect research subjects.
    [Show full text]